Cleared Traditional

K061548 - STRYKER URETERAL ILLUMINATION SYSTEM IV

K061548 is an FDA 510(k) clearance for STRYKER URETERAL ILLUMINATION SYSTEM IV, manufactured by Stryker Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FCS cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K061548 · Stryker Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
115d
Days
Class 2
Risk

K061548 is an FDA 510(k) clearance for the STRYKER URETERAL ILLUMINATION SYSTEM IV. Classified as Light, Catheter, Fiberoptic, Glass, Ureteral (product code FCS), Class II - Special Controls.

Submitted by Stryker Corp. (San Jose, US). The FDA issued a Cleared decision on September 28, 2006 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4020 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K061548

510(k) Number K061548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2006
Decision Date September 28, 2006
Days to Decision 115 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 131d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCS Device Classification - Class 2, Special Controls

Product Code FCS Light, Catheter, Fiberoptic, Glass, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4020
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FCS Light, Catheter, Fiberoptic, Glass, Ureteral

All 9
Devices cleared under the same product code (FCS) and FDA review panel - the closest regulatory comparables to K061548.
STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]
K151243 · Stryker Endoscopy · Aug 2015
STRYKER URETERAL ILLUMINATOR SYSTEM III
K982542 · Stryker Endoscopy · Sep 1998
URIGLOW TRANSILLUMINATING URETERIC STENT MODEL
K943801 · Rocket of London, Ltd. · Aug 1995
GABRIEL URETERAL ILLUMINATOR SYSTEM II
K945088 · Gabriel Medical, Inc. · Feb 1995
URETERAL ILLUMINATOR
K941506 · Apple Medical Corp. · Oct 1994
GABRIEL URETERAL ILLUMINATOR SYSTEM
K940019 · Gabriel Medical, Inc. · May 1994
K061548 · STRYKER URETERAL ILLUMINATION SYSTEM IV
Download PDF FDA Summary Stryker Corp.